BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    AMDS Hybrid Prosthesis ("AMDS")

    FDA UDI
    Artivion, Inc.·00877234001321·40mm – 30mm (Classic) Tapered Stent (28mm collar)

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033896·Baltic Denture System BDLoad BDLoad Mn6 PLSEbi...

    SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LYMPHA VISION-EXPERT

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007

    RAD-5 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·June 19, 2009

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·April 3, 2013

    CCU BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 23, 2011

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·April 25, 2008

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013